Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA videos nachrichten) announces that results of the phase III ADAGIO trial were presented today during the 12th Congress of European Federation of Neurological Societies (EFNS) in Madrid, Spain as part of a "Late Breaking News" session.

The ADAGIO study showed that Parkinson´s disease (PD) patients who took AZILECT(R) (rasagiline) 1mg tablets once-daily upon entry into the trial, demonstrated a significant improvement compared to those who initiated the drug 9 months later.

The 1mg dose met all three primary endpoints, as well as the secondary endpoint, with statistical significance. The primary analysis included three hierarchical endpoints based on Total-UPDRS (Unified Parkinson´s Disease Rating Scale) scores:

The safety profile of AZILECT(R) seen in the ADAGIO study was similar to previous experience with AZILECT(R).

Main results were presented at the congress by Professor Olivier Rascol, M.D., Ph.D., Department of Clinical Pharmacology, University Hospital, Toulouse, France, one of two principal investigators of the trial.

"The rigorous trial design and the fact that all three primary endpoints were met with statistical significance reinforce the quality of the data, supporting the potential for AZILECT(R) to have an effect on disease progression," said Prof. Rascol.

"The successful outcome of the study provides further rationale for the early use of AZILECT(R) among Parkinson´s disease patients," he added. "Delaying disease progression is the most important unmet need in the management of Parkinson´s disease," stated Prof. C. Warren Olanow, professor and chairman of the Department of Neurology at the Mount Sinai School of Medicine, New York, NY, and ADAGIO co-principal investigator.

"The ADAGIO study, the first of its kind, was prospectively designed to demonstrate if AZILECT(R) can slow down the progression of Parkinson´s disease. Results of the study show that early treatment with once-daily rasagiline 1mg tablets provided significant clinical benefits that were not obtained by those patients where initiation of AZILECT(R) therapy was delayed by nine months."

The ADAGIO study, one of the largest conducted in PD, included 1,176 patients with very early Parkinson´s disease in 14 countries and 129 medical centers who were randomized to receive rasagiline 1 or 2 mg/day for 72 weeks (early start) or placebo for 36 weeks followed by rasagiline 1 or 2 mg/day for 36 weeks (delayed start).

Description of trial results can be found online (http://www.abstracts2view.com/ana) in the abstract submitted by Prof. Olanow and Prof. Rascol to the 133rd Annual Meeting of the American Neurological Association, Salt Lake City, UT, September 21-24, 2008.

Prof. Olanow will be presenting these results during the Works in Progress poster session on Tuesday, September 23, 2008. The abstract was also chosen to be presented orally by Prof. Olanow on Tuesday from 11:45am-noon.

Teva intends to submit these results to the regulatory authorities in the U.S. and Europe. Based on these results, Teva will work with the regulatory authorities to incorporate the results into the label for AZILECT(R).

The primary analyses of the trial were based on change in total UPDRS (Unified Parkinson´s Disease Rating Scale) and included slope superiority of rasagiline over placebo in the placebo-controlled phase, change from baseline to week 72, and non-inferiority of early-start vs. delayed-start slopes during weeks 48-72 of the active phase. UPDRS is the most commonly used rating scale to assess disease status.

About AZILECT (R)

AZILECT(R) 1mg tablets (rasagiline tablets) are indicated for the treatment of the signs and symptoms of Parkinson´s disease both as initial therapy alone and to be added to levodopa later in the disease. AZILECT(R) 1mg tablets are currently available in 30 countries, including the US, Canada, Israel, Mexico, and most of the EU countries.

About Parkinson´s Disease

Parkinson´s disease is an age-related degenerative disorder of the brain.

Symptoms can include: tremor, stiffness, slowness of movement, and impaired balance. An estimated four million people worldwide suffer from the disease, which usually affects people over the age of 60.

About Teva

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world´s leading generic pharmaceutical company.

The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products.

Over 80 percent of Teva´s sales are in North America and Europe.

Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements. Such statements are based on management´s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva´s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements, including statements relating to the results of the ADAGIO phase III trial and the potential efficacy or future market or marketability of AZILECT(R).

Following further analysis, Teva´s interpretation of the results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this press release as there can be no guarantee that the results from the phase III trial discussed in this press release will be confirmed upon full analysis of the results of the trial and additional information relating to the safety, efficacy or tolerability of AZILECT(R) may be discovered upon further analysis of data from the phase III trial.

Even if the results described in this release are confirmed upon full analysis of the ADAGIO study, we cannot guarantee that AZILECT(R) will be approved for marketing in a timely manner, if at all, by regulatory authorities in the EU or in the U.S. Additional risks relating to Teva and its business are discussed in Teva´s Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

If we now turn to, you could say, the future growth drivers, then AJOVY is, of course, a key driver. As you all know, AJOVY is a drug in the new class of drugs that treat chronic migraine with fantastic clinical efficacy, basically reducing the number of migraine days on average by 50%, in some cases up 75% to 100% reduction of migraine days. So this is really a fantastic offering to patients. First time in 20 years that there is a real new therapy for migraine.

We are in this class together with two competitors, and we are very satisfied with the patient capture we see. We see that we roughly now capture around 30% of neutral brain patients, and we hope, of course, to be able to maintain this level going forward. A lot of new prescribers are coming every month, and we expect to grow the prescriber base on a steady basis over the coming years. So AJOVY is very important for our future growth, and we are very optimistic about the outlook.

Another strong driver is AUSTEDO. And as I said, it's having a high market share in Huntington's disease, in movement disorders in Huntington's, but it's also growing strongly in tardive dyskinesia. We have one competitor that's also in tardive dyskinesia and this is a new market where there's basically been really no therapy approved before AUSTEDO and the competing product. So here we are sort of opening up a new market.

And it's a big market, probably 0.5 million people in the U.S. suffer from tardive dyskinesia. So we do expect the patient numbers to keep on growing over many years, and as a consequence of this, we do expect, of course, also that the revenues of AUSTEDO will keep on growing. In '18, we exceeded the target we had of $200 million, and this is, of course, to keep growing going forward.

"We are targeting investments in our pipeline, we are targeting investments in biopharmaceuticals and biosimilars, and we are constantly optimizing our portfolio of both generic and innovative development projects.

On the debt side, we are committed to utilizing our cash to pay down debt and to continue to do so over the coming years. We have $1.7 billion that's scheduled for repayment in 2019. And we will have no liquidity issues with paying down net debt as we will also not have in the coming years. So basically, we have a financial outlook that is completely in line with the overall plan that we created more than a year ago.

This is a trough year as we are being saying for -- yes, well, since the beginning of the plan. This is the year where we bottom out on revenue and operating profit. And in 2020, we expect to return to growth and continue to do so in the coming years, based on the launches of the new products."

Q1 2019 No greater than 5.75xQ2 2019 No greater than 5.50xQ3 2019 No greater than 5.25xQ4 2019 No greater than 5.00xQ1 2020 No greater than 4.75xQ2 2020 No greater than 4.75xQ3 2020 No greater than 4.50xQ4 2020 No greater than 4.00xQ1 2021 No greater than 4.00xQ2 2021 No greater than 3.75xQ3 2021 No greater than 3.50xQ4 2021 No greater than 3.50x

McClellan (CFO): „Yeah. And if I could add to the debt question. First of all, we expect to pay down the $1.7 billion maturities in July through operating cash flow and cash on hand. We're not expecting to refinance. And second, we are actively starting discussions with our core banking group to look at reshaping our revolving credit facility to get out in front of getting it to the 12-month window of being current. So we're working on that. And we hope to conclude that in early 2019.“

Schultz: „So your first question on the 4 times net debt to EBITDA at end of 2020, you're absolutely right that it takes a bit of strong performance in 2020 to get to that at the end of 2020. So I won't be able to tell you firmly that we will for sure hit it exactly at the end of the fourth quarter of 2020. It could be that it's slightly later. What's most important is of course our long term financial target, which is 3 times. So going below 3 times net debt to EBITDA. And we'll be progressing towards that over the next three to five years. There will be no change in our strategy. So the exact timing remains to be seen. But the key important driver here is that we are driving towards a constant debt reduction over the coming years.“

"... Our principal sources of short-term liquidity are our existing cash investments, liquid securities and available credit facilities, primarily our $3 billionsyndicated revolving line of credit, which was not utilized as of September 30, 2018, as well as internally generated funds, which we believe are sufficient to meetour financial obligations in the ordinary course of business for at least twelve months. ..."

Aaron Gal Senior Analyst, Sanford C. Bernstein & Co. LLC "And third, more on the financial side. You're kind of guiding to like $1.8 billion in free cash flow in 2019. This is I guess the bucket from which you pay your debt down. And I'm kind of wondering if that number, just given how much it's lower than 2018, includes any assumptions about paydown off some sort of penalties or fines from some of the existing investigation, or this is kind of like a pure business decline from which we have to start our 2020 projections?"

Michael McClellan Chief Financial Officer & Executive Vice President, Teva Pharmaceutical Industries Ltd. "Yeah. So if we look at the difference between the $3.7 billion that we actually realized in 2018 and the – and say the $1.8 billion midpoint of the guidance, about $1 billion came off from special items that I mentioned earlier, the outlook and working capital and the Rimsa compensation.

Net income is down roughly $600 million to $700 million, so that drags. We will see less restructuring cash out. But we will have bonus payments in 2019 for the 2018 year, which we did not have in 2018 for the 2017 year.

But the thing that is probably abnormal, if you're looking for forward cash generation is, we do have a little bit of an overhang of all of the increase of rebates that have been happening. And in the second half of 2018, we'll have a little bit of a drag on the net receivables in 2019. So we'll have a $300 million to $400 million cash drag that should dissipate over the first couple quarters of 2019."

§Reuters•February 20, 2019WASHINGTON (Reuters) - The U.S. government has reached a settlement with Teva Pharmaceuticals Industries Ltd over charges that its agreements with rivals impeded consumer access to lower-priced generic drugs.

The Federal Trade Commission on Tuesday said it had settled three reverse payment fights with units of Teva, which will be prohibited from making similar agreements with competitors in the future.

The FTC has long fought against so-called "pay for delay" settlements, in which a brand-name drugmaker pays or otherwise compensates a generic rival to delay releasing a cheaper version of its product. The deal is often struck to resolve patent litigation.

"This broad settlement prevents the world’s largest manufacturer of generic drugs from entering into collusive agreements that prevent price competition by keeping generic drugs off the market," FTC Chairman Joe Simons said in a statement.

"We are very pleased to put these litigations against the FTC behind us," said Brendan O’Grady, a Teva executive vice president.

The FTC believes that paying rivals to stay off the market is a violation of antitrust law and fought one case to the Supreme Court, which agreed that it could be in some circumstances.

The agency has said that the deals cost consumers billions annually in higher drug costs.

In Congress, Senator Amy Klobuchar, a Democrat now running for president, and Senator Chuck Grassley, the Republican chair of the Judiciary Committee, introduced legislation in January to make such deals explicitly illegal.

The oldest of the three cases settled on Tuesday dates to 2009, when the FTC sued Solvay Pharmaceuticals for paying off Watson Pharmaceuticals, Par Pharmaceutical Co and Paddock Laboratories to delay bringing out a generic version of AndroGel, a testosterone cream. Watson is now owned by Teva.

The second case dates to 2014 and also involves AndroGel. In this instance, AbbVie Inc, which had acquired the drug, was accused of paying off Teva and another generic maker to again delay bringing out a cheaper version of the medicine.

In the third case, Endo Pharmaceuticals was accused of paying generic companies, including Watson, to refrain from bringing out a generic version of Lidoderm, which is used to relieve nerve pain. Endo settled with the FTC in 2017.

FTC litigation continues against Solvay and other of the brand name drug companies. The agency also said it would press on with a lawsuit accusing AbbVie and a partner for filing baseless patent litigation claims.